Juventas Therapeutics Reports 1 Year Data from P1 Heart Failure Clinical Trial
Their lead product, JVS-100, encodes Stromal cell-Derived Factor 1 (SDF-1) which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow.
- The 17-person, open-label, dose-escalation study targeted New York Heart Association (NYHA) class III heart failure patients;
- The clinical trial met its primary safety endpoint with no serious adverse events deemed drug related. 15 of the 17 patients survived to a year;
- Juventas recently presented the 12-month results from its P1 heart failure trial at the 7th International Conference on Cell Therapy for Cardiovascular Disease.
The Bottom Line: Based on these results, Juventas is preparing to enroll a placebo-controlled, randomized, double blinded P2 heart failure clinical trial in the US … to further define the efficacy of JVS-100. Importantly, patients receiving target therapeutic doses demonstrated clinically significant improvements at 12 months in 6 minute walk distance (6MWD) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Nearly 1/2 of the patients improved a full NYHA class, with multiple patients improving 2 full classes. To see clinical symptomatic benefits of this magnitude maintained from 4 to 12 months after JVS-100 treatment suggests JVS-100 is inducing fundamental and clinically significant improvements changes in the heart of treated patients